Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
NCT ID:
NCT01135368
Description:
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold:
5
Time Frame:
Starting with the first administration of study medication for up to 14 days after last dose of study medication.
Study:
NCT01135368
Study Brief:
Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lansoprazole | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months. | None | None | 82 | 506 | 114 | 506 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Subclavian artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Vascular pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.1) | View |
| Metastatic bronchial carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Ovarian cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Renal oncocytoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Seminoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Uterine cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Restless leg syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Brain stem infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Carotid sinus syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Cerebellar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Paresis cranial nerve | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Aortic valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Pleuropericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Colonic polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Rectocele | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Meniscus lesion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Post procedural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Generalised anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Panic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.1) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.1) | View |
| Jaundice cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.1) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Neuroborreliosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Papilloma viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Vulval abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Hyperventilation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Sudden hearing loss | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.1) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.1) | View |
| Vertigo positional | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Impaired healing | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.1) | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.1) | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.1) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.1) | View |
| Renal colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.1) | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.1) | View |
| Toe operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.1) | View |
| Oesophageal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Rectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Astrocytoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Bladder cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Breast cancer female | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Diffuse large B-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Gastrointestinal stromal tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Hepatic neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Hypopharyngeal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Nasopharyngeal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Oesophageal squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |